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Self-acupressure for Insomnia: A Pilot Randomized Controlled Trial
Abstract Objectives: To explore the clinical effects of self-acupressure for treating insomnia delivered by a training course. Hypothesis: Subjects who have participated in the self-acupressure training course will have greater improvement in insomnia symptoms and daytime impairment than the sleep hygiene education control group at 4 and 8 weeks. Design and subjects: A pilot randomized controlled trial. Subjects with insomnia will be recruited from the community. 30 subjects will be randomized to self-acupressure and sleep hygiene education control groups in a 1: 1 ratio. Study instrument: Insomnia Severity Index (ISI) will be used to assess insomnia symptoms and daytime impairment. Interventions: Subjects in the self-acupressure group will attend two training sessions to learn self-acupressure and will practice self-acupressure every night for 4 weeks; subjects in the sleep hygiene education control group will receive two training sessions to learn sleep hygiene practice. Main outcome measures: The primary outcome measure is the ISI score. Other measures include sleep parameters using subjective sleep diary, Hospital Anxiety and Depression Scale, and SF-6D at 4 and 8 weeks. Acceptability and sustainability of self-acupressure will also be evaluated. Data Analysis: Differences in the questionnaire scores, subjective sleep parameters will be examined using a mixed-effects model.
Age
All ages
Sex
ALL
Healthy Volunteers
No
School of Nursing, the Hong Kong Polytechnic University
Hong Kong, Hong Kong
Start Date
December 1, 2016
Primary Completion Date
March 3, 2017
Completion Date
March 31, 2017
Last Updated
February 16, 2017
30
ESTIMATED participants
Self-acupressure
OTHER
Sleep hygiene education
OTHER
Lead Sponsor
The Hong Kong Polytechnic University
NCT06032377
NCT06181643
Data Source & Attribution
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View ClinicalTrials.gov Terms and ConditionsNCT06807086